Major Depressive DisorderPhase 4VIVRENCT04448431
Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression
A Phase 4 study testing Vortioxetine and Desvenlafaxine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 80 sites in 12 countries.
Trial summary
The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Vortioxetine and Desvenlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 80 sitesin 12 countries
- Study dates
- 18 Jun 2020to 4 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current MDE must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a MADRS total score ≥24 at screening and baseline.
- The patient has had the current MDE for ≥3 months and < 12 months.
- The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with a partial response and is a candidate for a switch in the investigator's opinion.
- The patient wants to switch antidepressant treatment.
Who cannot join
- The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
- Other in- and exclusion criteria may apply
Trial locations and contacts
80 sites in 12 countries.
80 sites in 12 countries
Russia15 sites
Arkhangelsk Regional Clinical Mental Hospital
Arkhangelsk, 163530
GUZ Engels Psychiatric Hospital
Engel's, 413124
Moscow Scientific Research Institute of Psychiatry
Moscow, 107076
Clinic named after professor Yu. N. Kasatkin FGBOU DPO RMANPO Minzdrava Rossii
Moscow, 125284
Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...
Nizhny Novgorod, 603155
Leningrad Regional Psychoneurological Dispensary
Roshchino, Leningradskaya Oblast', 188820
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
Rostov-on-Don, 344022
LLC Medical Center Nova Vita
Rostov-on-Don, 344082
St. Nicolas State Psychiatric Hospital
Saint Petersburg, 190121
Hospital OrKli , LLC
Saint Petersburg, 199178
LLC Astarta
Saint Petersburg, 199226
Saratov State Medical University
Saratov, 410028
State Budgetery Educational Institution Of Higher Professional Education Smolensk State Medical U...
Smolensk, 214019
Region Specialized Psychiatric Hospital No.2
Stavropol Region, Kochubeev District, 357034
Yaroslavl Regional Clinical Psychiatry Hospital
Yaroslavl, 150003
Argentina14 sites
Clinica Privada Banfield
Banfield, Buenos Aires, B1828CKR
CINME (Centro de Investigaciones Metabolicas de Buenos Aires)
Buenos Aires, C1056ABJ
Cenydet-Centro Neurobiologico Y De Estres Traumatico-Biopsychomedical Research Group Srl
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1058AAJ
Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1133AAH
INAPsi (Instituto Nacional de Psicopatologia)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BOA
Sanatorio Prof. Leon S. Morra S.A.
Córdoba, Providencia de Cordo, X5009BIN
CEN (Centro Especializado Neurociencias)
Córdoba, 5000
Instituto Modelo de Neurologia Fundacion Lennox
Córdoba, X5000FAL
Instituto Medico DAMIC - Fundacion Rusculleda
Córdoba, X5003DCE
Clinica Privada De Salud Mental Santa Teresa De Avila
La Plata, Buenos Aires, 1900
Instituto De Neurociencias San Agustin SA
La Plata, Buenos Aires, B1900BHE
Centro De Asistencia E Investigacion En Neurociencias CENAIN
Mendoza, 5500
Resolution Psicopharmacology Research Institute
Mendoza, M5500BCR
CIAP (Centro de Investigacion y Asistencia en Psiquiatria)
Rosario, Santa Fe Province, 2000
Ukraine11 sites
CI of KRC Regional psychiatric and narcological medical association
Hlevakha, 8631
Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3
Ivano-Frankivsk, 76014
Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional clinical psychiatric hosp...
Kharkiv, Kharkivska, 61068
Academy of Medical Sciences of Ukraine - Institute of Neurology, Psychiatry and Narcology
Kharkiv, 61068
SI INPN Namsu
Kharkiv, 61068
Municipal Non-profit Enterprise Odesa Regional Psychiatric Hospital No.2 of Odesa Regional Council
Kominternivskyy, Odesa Oblast, 67513
Lviv Regional State Clinical Psychiatric Hospital, Lviv Danylo Galytsky National Medical University
Lviv, 79021
Odessa Regional Medical Centre of Mental Health
Odesa, 65006
Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology B...
Poltava, 36006
Communal Non-commercial Enterprise Cherkasy regional psychiatric hospital of Cherkasy regional co...
Smila, Cherkasy Oblast, 20708
Vinnitsa National Medical University
Vinnitsa, 21005
Czechia9 sites
Dr.Jan Holan MD, Office of
Brno, 61500
Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum
Havířov, 73601
Clinline services s.r.o.
Hostivice, 25301
Neuropsychiatrie HK, s.r.o.
Hradec Králové, 50009
National Institute of Mental Health
Klecany, 25067
Psychiatricka Ambulance
Kutná Hora, 28401
A-Shine s.r.o.
Pilsen, 31200
Clintrial s.r.o.
Prague, Prague 10, 100 00
Institut neuropsychiatricke pece
Prague, 18600
Bulgaria6 sites
MHAT Dr. Hristo Stambolski
Kazanlak, 6100
UMHAT Sv. Ivan Rilski EAD
Plovdiv, 4002
Center For Mental Health-Rousse
Rousse, 7003
MC Complete Medical Solutions
Samokov, 2000
Centre for Mental Health- Sofia
Sofia, 1202
Diagnostic Consultative Center Mladost-M Varna OOD
Varna, 9020
Slovakia6 sites
Psychiatricka ambulancia, MENTUM, s.r.o.
Bratislava, 82007
Epamed, S.R.O
Košice, 040 01
Psycholine S.R.O.
Rimavská Sobota, 97901
Crystal Comfort, s.r.o.
Vranov Nad Topou, 09301
BONA MEDIC s.r.o.
Zlaté Moravce, 95301
Psychiatricka Ambulancia
Zlaté Moravce, 95301
Sweden5 sites
Affecta Psyikiatri AB
Halmstad, 302 48
ProbarE i Lund
Lund, 22222
Smaert & Psykiatricentrum Malmoe
Malmö, Skåne County, 21137
ONE LIFETIME Lakarmottagning
Skövde, 541 50
ProbarE
Stockholm, 11329
Spain4 sites
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922
Hospital De La Santa Creu I Sant Pau
Barcelona, 08041
Centro De Salud Mental La Corredoria
Oviedo, Principality of Asturias, 33011
Hospital Psiquiatric de Palma de Mallorca
Palma de Mallorca, 07011
Belgium3 sites
Algemeen Ziekenhuis St. Lucas-St. Jozef
Bruges, 8310
SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel
Duffel, 2570
Cliniques De Mont-Godinne
Yvoir, 5530
Latvia3 sites
Psihiatrijas Centrs
Liepāja, Liepajas Rajons, 3401
Riga Centre Of Psychiatry And Addiction Disorders
Riga, 1005
Sigulda Hospital Outpatient Clinic
Sigulda, LV-2150
Mexico3 sites
Medical Care and Research S.A. de C.V.
Mérida, Yucatán, 97070
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100
CRI Centro Regiomontano de Investigacion SC
Monterrey, Nuevo León, 64060
About this study
Official title: A Randomised, Double-blind, Parallel-group, Active Controlled Study Evaluating the Efficacy of Vortioxetine Versus Desvenlafaxine in Adult Patients Suffering From Major Depressive Disorder With Partial Response to SSRI Treatment
The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit
Read the detailed description
The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit.
At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine, Desvenlafaxine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
10 or 20 mg/day, capsules, orally
DesvenlafaxineDrug
50 mg/day capsules, orally
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | 8 weeks treatment Receives: Drug: Vortioxetine |
| Desvenlafaxine | Active comparator | 8 weeks treatment Receives: Drug: Desvenlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
Measured: From baseline to Week 8
Secondary outcomes (15)
Remission (defined as a MADRS total score =<10)
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
Measured: At Week 8
Response (defined as a => 50% decrease from baseline in MADRS total score)
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
Measured: At Week 8
Change in MADRS anhedonia factor score
(based on items 1(apparent sadness),2 (reported sadness),6 (concentration difficulties),7 (lassitude),8 (inability to feel))
Measured: From baseline to Week 8
Change in Digital Symbol Substitution Test (DSST) total score
DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).
Measured: From baseline to Week 8
The proportion number of Hard Choice/number of High Reward trials and number of Low choice/number of Low Reward trials when performing the Effort- Expenditure for Rewards Task (EEfRT)
The EEfRT is a computerized task which measures reward motivation in which participants are presented with a series of repeated trials during which they choose between performing a ''hard-task'' or an ''easy-task'' in order to earn varying amounts of monetary rewards.
Measured: From baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
The CGI-S scale measures the severity of psychiatric symptoms on a 7-point scale from 1-7. The scores indicated the following: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The score ranged from 1-7, where 1 indicated absence of symptoms and higher score indicated greater severity of symptoms.
Measured: from baseline to Week 8
Clinical Global Impression Scale- Global Improvement (CGI-I) score
The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse)
Measured: at Day 7,28,56
Change in Functioning Assessment Short Test (FAST) total score
The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time
Measured: From baseline to Week 8
Change in FAST sub-domain scores
The FAST is a clinician-rated scale designed to assess difficulty in functioning. The FAST consists of 24 items in 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, leisure time. Each item is rated on a 4-point scale from 0 (no difficulty) to 3 (severe difficulty). The items are summed to yield a total score ranging from 0 to 72 with higher scores reflecting more serious difficulties.
Measured: From baseline to Week 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)
Measured: From baseline to Week 8
Change in Q-LES-Q work subscale
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)
Measured: From baseline to Week 8
Change in Q-LES-Q household duties subscale
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)
Measured: From baseline to Week 8
Change in Q-LES-Q school/course subscale
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)
Measured: From baseline to Week 8
Change in Q-LES-Q leisure time activities subscale
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)
Measured: From baseline to Week 8
Change in Q-LES-Q social relations subscale
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)
Measured: From baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start18 Jun 2020
- Primary completion6 Jan 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448431
- Sponsor's protocol ID
- 18498A
- Acronym
- VIVRE
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2020
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gill H, McIntyre RS, Christensen MC. Analysis of reward behavior in patients with MDD and partial response to SSRI therapy treated with vortioxetine versus desvenlafaxine: Experience with the Effort-Expenditure for Rewards Task (EEfRT) in the VIVRE study. J Affect Disord. 2025 Nov 1;388:119563. doi: 10.1016/j.jad.2025.119563. Epub 2025 May 31.
PubMed 40456468McIntyre RS, Florea I, Pedersen MM, Christensen MC. Head-To-Head Comparison of Vortioxetine Versus Desvenlafaxine in Patients With Major Depressive Disorder With Partial Response to SSRI Therapy: Results of the VIVRE Study. J Clin Psychiatry. 2023 May 22;84(4):23m14780. doi: 10.4088/JCP.23m14780.
PubMed 37227402
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Parallel-group, Active Controlled Study Evaluating the Efficacy of Vortioxetine Versus Desvenlafaxine in Adult Patients Suffering From Major Depressive Disorder With Partial Response to SSRI Treatment
- ClinicalTrials.gov ID
- NCT04448431
- Acronym / sponsor ID
- VIVRE / 18498A
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit
Detailed description
The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit.
At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: Vortioxetine8 weeks treatment |
| Desvenlafaxine | Active comparator | Drug: Desvenlafaxine8 weeks treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current MDE must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a MADRS total score ≥24 at screening and baseline.
- The patient has had the current MDE for ≥3 months and < 12 months.
- The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with a partial response and is a candidate for a switch in the investigator's opinion.
- The patient wants to switch antidepressant treatment.
Key exclusion criteria (2 listed)
- The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
- Other in- and exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetine10 or 20 mg/day, capsules, orally | Drug | Vortioxetine |
| Desvenlafaxine50 mg/day capsules, orally | Drug | Desvenlafaxine |
Primary outcome
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
Time frame: From baseline to Week 8
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
15 secondary outcomes
Remission (defined as a MADRS total score =<10)
Time frame: At Week 8
Response (defined as a => 50% decrease from baseline in MADRS total score)
Time frame: At Week 8
Change in MADRS anhedonia factor score
Time frame: From baseline to Week 8
Change in Digital Symbol Substitution Test (DSST) total score
Time frame: From baseline to Week 8
The proportion number of Hard Choice/number of High Reward trials and number of Low choice/number of Low Reward trials when performing the Effort- Expenditure for Rewards Task (EEfRT)
Time frame: From baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
Time frame: from baseline to Week 8
Clinical Global Impression Scale- Global Improvement (CGI-I) score
Time frame: at Day 7,28,56
Change in Functioning Assessment Short Test (FAST) total score
Time frame: From baseline to Week 8
Change in FAST sub-domain scores
Time frame: From baseline to Week 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score
Time frame: From baseline to Week 8
Change in Q-LES-Q work subscale
Time frame: From baseline to Week 8
Change in Q-LES-Q household duties subscale
Time frame: From baseline to Week 8
Change in Q-LES-Q school/course subscale
Time frame: From baseline to Week 8
Change in Q-LES-Q leisure time activities subscale
Time frame: From baseline to Week 8
Change in Q-LES-Q social relations subscale
Time frame: From baseline to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Derived from this study: PubMed 40456468Gill H, McIntyre RS, Christensen MC. Analysis of reward behavior in patients with MDD and partial response to SSRI therapy treated with vortioxetine versus desvenlafaxine: Experience with the Effort-Expenditure for Rewards Task (EEfRT) in the VIVRE study. J Affect Disord. 2025 Nov 1;388:119563. doi: 10.1016/j.jad.2025.119563. Epub 2025 May 31.
- Derived from this study: PubMed 37227402McIntyre RS, Florea I, Pedersen MM, Christensen MC. Head-To-Head Comparison of Vortioxetine Versus Desvenlafaxine in Patients With Major Depressive Disorder With Partial Response to SSRI Therapy: Results of the VIVRE Study. J Clin Psychiatry. 2023 May 22;84(4):23m14780. doi: 10.4088/JCP.23m14780.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
80 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine and Desvenlafaxine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 80 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in Russia, Argentina, Ukraine, Czechia, Bulgaria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score (time frame: From baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.